Εθνικό Σύστημα Διαπίστευσης ΑΕ
Hellenic Accreditation System
[pic]
|Annex to the G1/8 Certificate No. 907-2 |
| |
|SCOPE of ACCREDITATION |
|of the |
|Diagnostic Laboratory |
|of |
|LABOGEN Immunology Private Diagnostic Laboratory Medical S.A. (LABOGEN S.A.) |
|Materials/Products tested |Types of test/Properties measured |Applied methods/Techniques used |
| |
|Blood serum |Determination of 25 parameters |Automated immunochemical analyzer ABBOTT Architect |
| | |ci 16200, ci8200* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
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|Blood serum (continued) | | |
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| |1.Glucose |Colorimetric assay with Hexokinase /G-6-PDH |
| |2.Urea |Urease Method |
| |3.Creatinine |JAFFE Method Kinetic Alkaline Picrate |
| |4.Uric acid |Hexokinase Method |
| |5.Triglycerides |Enzymatic reaction with Glycerol Phosphate Oxidase |
| |6.Cholesterol (total) |Enzymatic reaction |
| |7.Cholesterol (HDL) |Enzymatic reaction with Accelerator Selective |
| | |Detergent |
| |8.Aspartateaminotransferase (AST/GOT) |NADH (without P-5’-P) |
| |9.Alanine aminotransferase (ALT/GPT) |NADH (without P-5’-P) |
| |10.Gamma-glutamyl trasferase (γ-GT) |Enzymatic reaction with |
| | |L-gamma-glutamyl-3-carboxy-4-nitroanilide Substrate |
| |11.Alkaline Phosphatase(ALP) |Colorimetric assay with Para-nitrophenyl Phosphate |
| |12.Creatine kinase (CPK) |Colorimetric assay with N-acetyl-L-cysteine (NAC) |
| |13.Lactate dehydrogenase (LDH) |IFCC, lactate to pyruvate |
| |14.Amylase |Enzymatic kinetic with CNPG3 Substrate |
| |15.Total Protein (TP) |Biuret Method |
| |16.Albumin (ALB) |Colorimetric assay with Bromocresol purple |
| |17.Total Bilirubin (TBIL) |Diazonium salt |
| |18.Direct Bilirubin (DBIL) |Diazo reaction |
| |19.Iron (Fe) |Colorimetric assay with Ferene |
| |20.Potassium (K) |Indirect, with ion-selective electrode diluted |
| | |potentiometry |
| |21.Sodium (Na) |Indirect, with ion-selective electrode diluted |
| | |potentiometry |
| |22.Clorine (Cl) |Indirect, with ion-selective electrode diluted |
| | |potentiometry |
| |23.Calcium (Ca) |Colorimetric assay with Arsenazo III |
| |24.Phosphorus (P) |Photometric with Phosphomolybdenic Acid |
| |25.Magnesium (Mg) |Enzymatic (isocitrate deydrogenase) |
| |Determination of 8 parameters |Automated immunochemical analyzer ABBOTT Architect |
| | |ci16200* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |1.Immunoglobulin Α (IgG) |Immunoturbidimetric |
| |2.Immunoglobulin G (IgA) | |
| |3.Immunoglobulin Μ (IgM) | |
| |plement C3 | |
| |plement C4 | |
| |6.C reactive protein CRP |Immunoturbidimetric with latex |
| | |microparticles |
| |7.Rheumatoid Factor RF | |
| |8.Antistreptolycin-O (ASO) | |
|Immunological Tests |
| |Determination of 3 parameter |Automated immunochemical analyzer ABBOTT Architect |
|Blood serum | |ci 16200, ci8200 * |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
| |1.Ferritin (Ferr) |Chemiluminescent Microparticle Immunoassay CMIA |
| |2.Vitamin B-12 | |
| |3.Folate acid | |
| |Determination of 1 parameter |Automated immunochemical analyzer ABBOTT Architect |
| | |ci8200* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |Insulin |Chemiluminescent Microparticle Immunoassay CMIA |
| |Determination of 1 parameter |Automated immunochemical analyzer ABBOTT Architect |
| | |ci16200* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |Valproic Acid |Chemiluminescent Microparticle Immunoassay CMIA |
| |Determination of 3 parameters |Automated immunochemical analyzer ABBOTT Architect |
| | |i2000* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |1.Thyroid - stimulating hormone (TSH) |Chemiluminescent Microparticle Immunoassay CMIA |
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| |2.Parathormone (PTH) | |
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| |3. 25 (ΟΗ) Vitamin D | |
| |Determination of 12 parameters |Automated immunochemical analyzer ADVIA CENTAUR XP* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |1.Triidothyronine total (T3) |Chemiluminescent CLIA |
| |2.Free Triidothyronine (FT3) | |
| |3.Thyroxin total (T4) | |
| |4.Free Thyroxin (FT4) | |
| |5.Thyroid - stimulating hormone (TSH) | |
| |6.Alpha-fetoprotein (AFP) | |
| |7.Carcinoembryonic antigen (CEA) | |
| |8.Prostate-specific antigen (PSA) | |
| |9.Cancer marker CA 15.3 | |
| |10.Cancer marker CA 125 | |
| |11.Cancer marker CA 19.9 | |
| |12.Immunoglobulin E (IgE) | |
| |Determination of 16 parameters |Automated immunochemical analyzer COBAS e601 Roche* |
| | |Παράρτημα 1 εγχειριδίου ποιότητας έκδοση 5/8.10.2019|
| |1.Follicle stimulating hormone (FSH) |Electrochemiluminescence Immunoassay ECLIA |
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| |2.Luteinizing Hormone | |
| |(LH) | |
| |3.Prolactin (PRL) | |
| |4.Estradiol (E2) | |
| |5.Progesterone (PRG) | |
| |6.B-Human chorionic gonadotropin (β-HCG) | |
| |7.Total Testosterone (TESTO-T) | |
| |8.Dehydroepiandrosterone-sulfate (DHEA-S) | |
| |9.Sex hormone-binding globulin (SHBG) | |
| |10.Cortisol (CORT) | |
| |11.Thyroglobubin (Tg) | |
| |12.Hepatitis B surface antigen (HBsAg) | |
| |13.Hepatitis B surface antibody(HBsAb | |
| |14.Hepatitis C antibodies (anti HCV) | |
| |15.HIV1/2 antibodies & HIV1 p24 antigen (Anti HIV) | |
| |16.Hepatitis A total antibodies(anti HAV) | |
| |Determination of 8 parameters |Automated immunochemical analyzer ABBOTT Alinity* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |1.Toxoplasma IgG antibodies |Chemiluminescent Microparticle Immunoassay CMIA |
| |2.Toxoplasma IgM antibidies | |
| |3.Rubella virus IgG antibodies | |
| |4.Rubella virus IgM antibodies | |
| |5.Cytomegalovirus IgG antibodies (CMV IgG) | |
| |6.Cytomegalovirus IgM antibodies (CMV IgM) | |
| |7.ΕΒV IgG-Epstein Barr Virus Antibody IgG | |
| |8. ΕΒV IgM- Epstein Barr Virus Antibody IgM | |
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|Immunochemical Tests |
|Blood serum |Determination of 201 allergens (Specific immunoglobulin IgE - |Automated immunochemical analyzer Immulite 2000 XPi*|
| |RAST) |Quality Manual Annex 1 version 5/8.10.2019 |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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|Blood serum (continued) | | |
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| |c1 Penicilloyl G | |
| | |Chemiluminescent CLIA |
| |c2 Penicilloyl V | |
| |c203 Ampicillin | |
| |c204 Amoxicillin | |
| |d1 Dermatophagoides pteronyssinus | |
| |d2 Dermatophagoides farinae | |
| |d3 Dermatophagoides microceras | |
| |d70 Acarus siro | |
| |d71 Lepidoglyphus destructor | |
| |d72 Tyrophagus putrescentiae | |
| |d73 Glycyphagus domesticus | |
| |e1 Cat Dander-Epithelium | |
| |e2 Dog epithelium | |
| |e3 Horse dander | |
| |e4 Cow dander | |
| |e5 Dog dander | |
| |e70 Goose feathers | |
| |e71 Mouse epithelium | |
| |e80 Goat epithelium | |
| |e81 Sheep epithelium | |
| |e82 Rabbit epithelium | |
| |e85 Chicken feathers | |
| |e86 Duck feathers | |
| |e215 Pigeon feathers | |
| |f1 Egg white | |
| |f2 Milk | |
| |f3 Codfish | |
| |f4 Wheat | |
| |f5 Rye | |
| |f6 Barley | |
| |f7 Oat | |
| |f8 Corn | |
| |f9 Rice | |
| |f10 Sesame seed | |
| |f11 Buckwheat | |
| |f12 Green pea | |
| |f13 Peanut | |
| |f14 Soybean | |
| |f15 White bean | |
| |f17 Hazelnut | |
| |f18 Brazil nut | |
| |f20 Almond | |
| |f23 Crab | |
| |f24 Shrimp | |
| |f25 Tomato | |
| |f26 Pork | |
| |f27 Beef | |
| |f31 Carrot | |
| |f33 Orange | |
| |f35 Potato | |
| |f36 Coconut | |
| |f37 Blue Mussel | |
| |f40 Tuna | |
| |f41 Salmon | |
| |f44 Strawberry | |
| |f45 Baker's yeast | |
| |f47 Garlic | |
| |f48 Onion | |
| |f49 Apple | |
| |f59 Octopus | |
| |f61 Sardine | |
| |f75 Egg yolk | |
| |f76 Alpha Lactalbumin | |
| |f77 Beta Lactoglobulin | |
| |f78 Casein | |
| |f79 Gluten | |
| |f80 Lobster | |
| |f81 Cheese,Cheddar | |
| |f82 Cheese,Mold-type | |
| |f83 Chicken meat | |
| |f84 Kiwi Fruit | |
| |f85 Celery | |
| |f86 Parsley | |
| |f87 Melon | |
| |f88 Lamb | |
| |f89 Mustard | |
| |f90 Malt | |
| |f92 Banana | |
| |f93 Cacao | |
| |f94 Pear | |
| |f95 Peach | |
| |f96 Avocado | |
| |f105 Σοκολάτα | |
| |f170 Swiss cheese | |
| |f202 Cashew | |
| |f203 Pistachio | |
| |f204 Trout | |
| |f208 Lemon | |
| |f210 Pineapple | |
| |f212 Mushroom | |
| |f213 Rabbit | |
| |f214 Spinach | |
| |f215 Lettuce | |
| |f216 White cabbage | |
| |f221 Coffee | |
| |f222 Tea | |
| |f231 Boiled milk | |
| |f232 Ovalbumin | |
| |f233 Ovomucoid | |
| |f235 Lentil | |
| |f237 Apricot | |
| |f242 Cherry | |
| |f245 Egg | |
| |f247 Honey | |
| |f255 Plum | |
| |f256 Walnut | |
| |f258 Squid | |
| |f259 Grape | |
| |f260 Broccoli | |
| |f262 Eggplant | |
| |f280 Black Pepper | |
| |f284 Turkey Meat | |
| |f291 Cauliflower | |
| |f299 Chestnut | |
| |f302 Mandarin | |
| |f309 Chick pea | |
| |f402 Fig | |
| |f409 Goat's Milk | |
| |g1 Sweet Vernal Grass | |
| |g2 Bermuda grass | |
| |g3 Orchard grass | |
| |g4 Meadow Fescue | |
| |g5 Perennial Rye grass | |
| |g6 Timothy grass | |
| |g7 Common Reed Grass | |
| |g8 June Grass | |
| |g9 Red Top | |
| |g10 Johnson Grass | |
| |g11 Brome Grass | |
| |g12 Cultivated Rye Grass | |
| |g13 Velvet grass | |
| |g14 Cultivated Oat Grass | |
| |g15 Cultivated Wheat Grass | |
| |g16 Meadow Foxtail Grass | |
| |g17 Bahia grass | |
| |g70 Wild Rye Grass | |
| |g71 Canary Grass | |
| |g202 Cultivated Corn | |
| |h1 House dust -Greer | |
| |i1 Honey Bee venom | |
| |i2 White-faced Hornet | |
| |i3 Yellow Jacket Venom | |
| |i4 Paper wasp Venom | |
| |i5 Yellow hornet | |
| |i6 Cockroach | |
| |i70 Imported Fire Ant | |
| |i71 Mosquito | |
| |i75 European Hornet | |
| |k20 Wool | |
| |k74 Silk | |
| |k82 Latex | |
| |m1 Penicillium notatum | |
| |m2 Cladosporium herbarum | |
| |m3 Aspergilus fumigatus | |
| |m4 Mucor racemosus | |
| |m5 Candida albicans | |
| |m6 Alternaria tenuis | |
| |m7 Botrytis cinerea | |
| |m8 Helminthosporium halodes | |
| |m9 Fusarium moniliforme | |
| |m207 Aspergillus niger | |
| |p1 Ascaris | |
| |p4 Anisakis | |
| |t1 Maple | |
| |t2 Alder | |
| |t3 Birch | |
| |t4 Hazelnut | |
| |t5 Beech | |
| |t6 Mountain Cedar | |
| |t7 Oak | |
| |t8 Elm | |
| |t9 Olive | |
| |t10 Walnut | |
| |t11 Sycamore | |
| |t12 Willow | |
| |t14 Cottonwood | |
| |t15 White Ash | |
| |t16 White Pine | |
| |t18 Eucalyptus | |
| |t19 Acacia | |
| |t23 Italian Cypress | |
| |t70 White Mulberry | |
| |t201 Spruce | |
| |t210 Privet | |
| |w1 Common Ragweed | |
| |w2 Western Ragweed | |
| |w3 Giant Ragweed | |
| |w4 False Ragweed | |
| |w5 Wormwood | |
| |w6 Mugwort | |
| |w7 Ox-Eye Daisy | |
| |w8 Dandelion | |
| |w9 English Plantain | |
| |w10 Lamp's Quarters | |
| |w11 Russian Thistle | |
| |w12 Goldenrod | |
| |w13 Cocklebur | |
| |w14 Rough Pigweed | |
| |w16 Rough Marsh Elder | |
| |w18 Sheep Sorrel | |
| |w19 Parietaria officinalis | |
| |w20 Nettle | |
| |w21 Parietaria Judaica | |
|Blood serum |Determination of 16 allergens panels |Automated immunochemical analyzer Immulite 2000 XPi*|
| | |Quality Manual Annex 1 version 5/8.10.2019 |
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| |EP1 Animal panel 1 - (E1, E3, E4, E5) |Chemiluminescent CLIA |
| |EP71 Animal panel 71 - (E70, E85, E86, E89) | |
| |FP1 Food panel 1 - Nut Mix (f13,17,18 ,20,36) | |
| |FP2 Food panel 2 - Fish/Shell (f3,24,37,40,41) | |
| |FP3 Food panel 3 - Cereals Mix (f4,7,8,10,11) | |
| |FP73 Food panel 73 - Meat Mix (f26,27,83,88) | |
| |FP13 Food panel 13 (f12,15,31,35) | |
| |FP15 Food panel 15 - Fruit Mix (f33,49,92,95) | |
| |GP1 Grass panel 1 (g3,4,5,6,8) | |
| |GP4 Grass panel 4 (g1,5,7,12,13) | |
| |HP1 House panel 1(d1,d2,h1,i6) | |
| |MP1 Mold panel 1 (m1,2,3,5,6) | |
| |TP5 Tree panel 5 (t2,4,8,12,14) | |
| |TP6 Tree panel 6 (t1,3,5,7,10) | |
| |WP1 Weed panel 1 (w1,6,9,10,11) | |
| |WP5 Weed panel 5 (w1,6,7,8,12) | |
| |
|Hematological Tests |
|Whole blood (EDTA) |Determination of 1 parameter |Chromatographic analyzer VARIANT II TURBO Bio-Rad* |
| | |Quality Manual Annex 1 version 5/8.10.2019 |
| |1.Determination of glycated hemoglobin A1c (HbA1C ) |HPLC (ion exchange High-performance chromatography) |
* Reference to the commercial name of a specific analyzer refers to a specific analytical method and protocol
Site of assessment: Permanent premises, 37-39 Antheon str., Athens, Greece.
Approved signatories: F. Vlasopoulou, P. Makridou.
This scope of Accreditation replaces the previous one dated 20.12.2021.
The Accreditation Certificate No. 907-2, to ELOT EN ISO 15189:2012, has been expanded until 13.08.2022.
Athens, Junuary 10, 2022
Christos Nestoras
CEO of ESYD
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Biochemical Testing
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